Response and Remediation
US FDA Response and Remediation
We help clients with their response and remediation of 483s, Warning Letters, and Consent Decrees. Exemplar Compliance understands that the success or failure of your FDA remediation effort directly impacts your business and your financial future. We equip you with former FDA and Industry Experts who provide insight and hands-on experience. We work with your management team to evaluate current quality and compliance risks and implement effective solutions that make sense for your business. Additionally, we assist with the preparation of FDA responses that implement corrective actions based on science and data.
Our team has a broad understand of regulatory expectations and an extensive background in FDA remediation.
Exemplar Compliance works with your organization to provide:
- Remediation solutions focused on FDA regulations and guidance documents.
- A cooperative working environment where we educate clients.
- Scientifically based response plans.
- Quality investigations and CAPA.
- Remediation of procedures, work instructions, and training
- Project Management for site/corporate FDA remediation activities
Remediation Outside of the US
Do you need assistance with response or remediation for products marketed outside of the United States? We perform gap assessment and remediation activities for numerous regions outside of the US including:
- Japan – MHLW
- China – SFDA
- Brazil – ANVISA
- Canada – Health Canada
- Europe – EMEA
- UK – MHRA
- Australia – TGA
Our former FDA and industry experts have an average of 25 years of experience.
Some of Our Work
FDA 483 Remediation for a Biologic Product
Our Client 1
We worked closely with our client to efficiently address 483 observations as part of a PreApproval Inspection. We able to used a CAPA format to thoroughly investigate each issue and provide a quick resolution.
FDA Warning Letter Response for a Drug Manufacturer
Our Client 2
We worked closely with our client to develop a comprehensive FDA Warning Letter Response package comprising of individual responses to each observation, objective evidence for all corrections made and, a detailed project plans to share with the US FDA.
FDA Class 1 Recall Response and Reinspection for a Foreign Manufacturer
Our Client 3
We assisted a foreign manufacturer with a class 1 recall and subsequent re-inspection of their facility by US FDA. The result was a “closed” recall and a successful inspection by FDA, enabeling them to keep their products on the market.